The purpose of this study is to assess the safety and tolerability of ziprasidone during long-term open-label administration in children and adolescents (ages 10-17) with bipolar I disorder (manic or mixed)
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
169
Study medications will include oral ziprasidone capsules of 20 mg, 40 mg, 60 mg, and 80 mg strength. Subjects will be dosed daily for 26 weeks using a flexible dose design with a minimal dose range of 20mg bid to a maximum dose range of 80 mg bid .
Young Mania Rating Scale (YMRS) Total Score Change From Baseline
YMRS: 11-item instrument with scales 0 (normal) to 4 (highest abnormal)for 7 items and 0 (normal) to 8 (highest abnormal) for 4 items. Total possible 0 - 60. Baseline is from parent study A1281132.
Time frame: baseline and 26 Weeks; 26 Weeks Last Observation Carried Forward (LOCF)
Clinical Global Impression of Severity (CGI-S) Change From Baseline
CGI-S Scale:standardized assessment tool to rate severity of subject's illness; assesses investigator's impression of subject's current illness state. Change: score at observation minus score at baseline. Score: 1 (not ill at all) to 7 (among most extremely ill). Baseline = last available observation from parent double-blind study(A1281132).
Time frame: baseline and 26 Weeks; 26 Weeks LOCF
Incidence of Lab Abnormalities
number of subjects with an abnormal lab value for those parameters with 5% or greater incidence of abnormality.
Time frame: Week 26
Change in Low-Density Lipoprotein (LDL) Cholesterol and Fasting Cholesterol
Mean Change: lab value at observation minus lab value at baseline.
Time frame: Week 6, Week 26
Change in Hormones
Mean Change: lab value at observation minus lab value at baseline
Time frame: Week 6, Week 26
Mean Change From Baseline in Supine Systolic Blood Pressure
Mean Change: vital sign value at observation minus vital sign value at baseline
Time frame: Week 1 through Week 26
Mean Change From Baseline in Supine Diastolic Blood Pressure
Mean Change: vital sign value at observation minus vital sign value at baseline
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Pfizer Investigational Site
Scottsdale, Arizona, United States
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...and 31 more locations
Time frame: Week 1 through Week 26
Mean Change From Baseline in Supine Pulse Rates
Mean Change: vital sign value at observation minus vital sign value at baseline
Time frame: Week 1 through Week 26
Mean Change From Baseline in Standing Systolic Blood Pressure
Mean Change: vital sign value at observation minus vital sign value at baseline
Time frame: Week 1 through Week 26
Mean Change From Baseline in Standing Diastolic Blood Pressure
Mean Change: vital sign value at observation minus vital sign value at baseline
Time frame: Week 1 through Week 26
Mean Change From Baseline in Standing Pulse Rates
Mean Change: vital sign value at observation minus vital sign value at baseline
Time frame: Week 1 through Week 26
Mean Change From Baseline for Body Weight
Mean change; body weight value at observation minus body weight value at baseline.
Time frame: Week 6, Week 26
Mean Change From Baseline for Body Mass Index (BMI) Z-Score
mean change in body weight BMI -Z score calculated by subtracting median reference value of the population from observed value and dividing by standard deviation of reference population (kg/m squared). 0=no change
Time frame: Week 6, 26, early termination
Body Mass Index (BMI) Z-score Frequency
change in body weight BMI -Z score calculated by subtracting median reference value of the population from observed value and dividing by standard deviation of reference population (kg/m squared). 0=no change
Time frame: Week 6
Body Mass Index (BMI) Z-score Frequency
change in body weight BMI -Z score calculated by subtracting median reference value of the population from observed value and dividing by standard deviation of reference population (kg/m squared). 0=no change
Time frame: Week 26
Mean Change From Baseline for QTcF Intervals
QT intervals (observed in an electrocardiogram)corrected using Fridericia's formula (QTcF). Mean change: mean change of observation minus baseline. Baseline: last available observation in the parent double-blind study.
Time frame: Baseline to Week 26 (end of study)
Frequency of Largest Categorical Increases in QTcF for Males
QT intervals (observed in an electrocardiogram) corrected with Fridericia's Formula (QTcF). Number of subjects with corresponding categorical increase in QTcF.
Time frame: Week 26 (end of study)
Frequency of Largest Categorical Increases in QTcF for Females
QT interval (observed in an electrocardiogram) corrected using Fridericia Formula (QTcF). Number of subjects with corresponding categorical increase in QTcF.
Time frame: Week 26 (end of study)
Frequency of Largest Categorical Increases in QTcF - All Subjects
QT intervals (observed in an electrocardiogram)corrected using Fridericia Formula (QTcF). Number of subjects with corresponding categorical increase in QTcF.
Time frame: Week 26 (end of study)